Status:
COMPLETED
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Hematologic Malignancy
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administ...
Eligibility Criteria
Inclusion
- Age \> 18
- Relapsed or refractory hematologic malignancies including AML, ALL, CLL, high risk myelodysplasia (International Prognostic Score \>2.5), CML blast crisis, multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma for which all potentially curative therapy options have been exhausted.
- ECOG (Eastern Cooperative Oncology Group) performance status \< 2.
- Biochemical values within the following range:
- Serum creatinine \< 2x upper limit of normal.
- Total bilirubin \< 2x upper limit of normal, AST (asparatate aminotransferase) and ALT (alanine aminotransferase) \< 5x upper limit of normal.
- Ability to maintain adequate oral intake of medication.
- Ability to understand and sign informed consent.
- Toxicity from prior chemotherapy has resolved
Exclusion
- Uncontrolled systemic infection.
- Uncontrolled intercurrent illness
- Pregnant or breast feeding
- Active CNS (central nervous system) disease
- Neurologic symptoms related to intracurrent illnesses or unexplained causes
- Psychiatric illness that would limit compliance with study
- Receiving other systemic chemotherapy, other than hydroxyurea to control circulating blast counts, within 10 days of study entry. Hydroxyurea is permitted, however the dose must be stable and unchanged in the 7 days prior to initiation with ciclopirox olamine
- Concurrent therapy with topical ciclopirox olamine.
- Use of other investigational anti-cancer therapy within two weeks of study entry.
- Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.
- Resting ejection fraction \< 50%
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00990587
Start Date
October 1 2009
Last Update
June 22 2015
Active Locations (2)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9